Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8043235

FEI Number

2981

Entity Name

NORTH EOS INDUSTRIES, INC.

City/State/Country

TAICHUNG CITY, TW

Establishment Address

NO. 46, ZHONGTAI STREET, TUNG-SHIH DISTRICT, TAICHUNG CITY 423, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

NORTH EOS INDUSTRIES, INC. (Owner Number: 8043235)

Owner / Operator Contact Address

46, ZHONG TAI STREET, TUNG-SHIH DISTRICT, TAICHUNG CITY, TW-NOTA 423, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Eyelid Speculum EOS EyelidSpec EOS BRAND DISPOSABLE EOSOTOSPEC EOS BRAND SUCTION EosChamber II -light uterine dilator EOS BRAND DentSpec NasalSpec EOS BRAND EOSCURETTE EosStethoscope EosBrush, EosSmear DentBox EOS BRAND ProctoSpec EOSLED EosBeauty Tray ProctoSpec Proctoscope DentSpec EOS BRAND DISPOSABLE ORAL EXPANDER EosProbe

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HNI	Retractor, Ophthalmic	Ophthalmic	Class 1	886.4350	1994-01-11
EPY	Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	2006-11-28
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2000-09-07
HJN	Transilluminator, Battery-Powered	Ophthalmic	Class 1	886.1945	2018-08-12
HDQ	Dilator, Cervical, Fixed Size	Obstetrics/Gynecology	Class 1	884.4530	2004-12-21
EIF	Accessories, Retractor, Dental	Dental	Class 1	872.4565	2018-04-30
LWF	Dilator, Nasal	Ear, Nose, Throat	Class 1	874.3900	2004-11-15
JYG	Curette, Ear	Ear, Nose, Throat	Class 1	874.4420	2006-11-16
HGN	Stethoscope, Fetal	Obstetrics/Gynecology	Class 1	884.2900	2018-08-12
HHT	Spatula, Cervical, Cytological	Obstetrics/Gynecology	Class 2	884.4530	2008-01-18
EFT	Cleanser, Denture, Over The Counter	Dental	Class 1	872.3520	2001-03-12
FFQ	Speculum, Rectal	Gastroenterology, Urology	Class 1	876.4730	2018-01-13
HJD	Illuminator, Color Vision Plate	Ophthalmic	Class 1	886.1160	2017-12-27
KBN	Gag, Mouth	Ear, Nose, Throat	Class 1	874.4420	2018-01-25
GCP	Endoscope, Ac-Powered And Accessories	Gastroenterology, Urology	Class 2	876.1500	2008-01-18
FZW	Expander, Surgical, Skin Graft	General, Plastic Surgery	Class 1	878.4800	1993-11-10
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2018-08-12

Official Correspondent

TSAI YIH-CHIOU

US Agent Details

Steven Baker Business: i-SMART Consulting US LLC Email: s.baker.ismart@gmail.com Phone: (267) 4321045

Related Public Records

Same Entity

NORTH EOS INDUSTRIES, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K834189	Imm Enterprises , Ltd.	JAKOBI SURG. INSTRUMENTS #7 44/47	1984-03-06
K963801	Young OU Brush Co.	PAP BRUSH	1997-04-09
K902838	Denture Dynamic'S, Inc.	DENTURE DYNAMIC'S DENTURE MAGIC	1990-09-06
K932506	Rudolf Riester GmbH & Co. KG	RI-SCOPE (S)	1993-10-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2013	Invuity, Inc.	2	BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.

Similar Registrations

Registration Number	Establishment Name	Location
3015177648	KATENA PRODUCTS, INC.	Parsippany, NJ, US
2529846	MED SAVER, INC.	PHOENIXVILLE, PA, US
3003435550	HAFNER CHIRURGISCHE INSTRUMENTE	BALGHEIM Baden-Wurttemberg, DE
3004001706	BR SURGICAL LLC	Jacksonville, FL, US
3011110913	APPASAMY ASSOCIATES PRIVATE LIMITED (MN KUPPAM)	Villupuram District Tamil Nadu, IN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8043235. Last updated year: 2026. Please use registration number 8043235 when referencing this establishment in official correspondence.